We are currently partnering with a Biotech company who are developing antibody-based therapies for the treatment of cancer. They have a leading treatment which they are looking to launch over the course of this year / next.
They are requiring a QA Specialist for a 6 month contract based in there office in Zug, Switzerland. This position will support the manufacturing and testing of GMP materials with a focus on batch. This would be a asap start and requires a local person already living in Switzerland. Some of the key points are outlines below :-
Responsibilities:
- Manage lot review activities for GMP Intermediates, APIs, and Drug Products to ensure disposition timelines are
- Review executed batch production records and deviations from external suppliers to ensure compliance with approved procedures, quality agreements and GMP expectations.
- Compile and manage lot
- Enter data in to process monitoring
- Interface diligently with local and global teams to ensure efficient and effective communication on project status and
Experence needed:
- Knowledge and experience with US/EU GMPs, ICH and other applicable international regulations.
- Experience with the production and testing of pharmaceuticals (biologics or small molecules) and review of production
- Good communication skills and proven ability to work well with internal and external teams.
- Fluency in English is a must
- Minimum of Bachelor's degree in a scientific discipline (Chemistry, Biology)
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